Dillon-Spruill, MeganStanton, Douglas2025-07-232025-07-232025-07-22http://hdl.handle.net/10342/14222International Council on Harmonisation (ICH) E8(R1) guidance recommends proactive clinical trial planning to ensure participant safety and study integrity (ICH, 2021). By applying these concepts during trial implementation planning, investigative sites can have a more robust approach to detecting, remediating, and preventing errors. Following a literature review, FOCUS-PDSA was utilized by a quality improvement team (QIT) in developing a tool to introduce Quality by Design (QbD) concepts for study plan development. A narrated slide presentation was provided to orient staff. The project was implemented from January 13, 2025, through April 25, 2025, over four clinical trial studies. An anonymous survey was conducted among the eight research coordinators participating in the pilot, assessing the use of the tool in terms of clarity, ease of use, impact on time management, and knowledge gained in QbD concepts. Four surveys were returned, with respondents indicating an increased knowledge of QbD post-pilot, openness to further QbD education, general satisfaction with the tool, and content relevant to their role. However, responses indicated some were open to future use of QbD in study planning, while others were unsure. Comments suggested more guidance on identifying critical factors and developing comprehensive study plans. Clinical trial research is essential to advancing medical knowledge as a critical arm of translational science. Safeguarding participant safety and trial integrity through protocol development and study implementation planning is paramount. Although demonstrated through a small sample of survey returns, utilizing QbD methodologies shows potential benefits during trial implementation planning at the investigative site level.en-USClinical trial, Critical to quality factors, Investigative site, Quality by DesignDNP Executive Summary